Label: SCALPICIN MAXIMUM STRENGTH- hydrocortisone liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 26, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch liquid

  • Uses

    • temporarily relieves itching associated with minor skin irritations and rashes due to
      • seborrheic dermatitis
      • eczema
      • psoriasis
    • other uses of this product should be only under the advice and supervision of a doctor
  • Warnings

    For external use only

    Flammable. Keep away from fire, flame or heat.

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use; ask a doctor
    • twist the flow-control cap to open
    • if using after shampooing, towel dry hair
    • apply from bottle directly to scalp, massage in
    • to avoid running or dripping, do not squeeze bottle too hard
  • Other information

    • store at 20-25°C (68-77°F)
    • protect from humidity
    • Keep carton for full directions for use.
  • Inactive ingredients

    alcohol denat., water, propylene glycol, PEG-40/polysilicone, glycerin, dipropylene glycol, menthol, disodium EDTA, aloe barbadensis leaf juice, melaleuca alternifolia (tea tree) leaf oil, tocopheryl acetate

  • Questions?

    1-888-963-3382

    You may also report side effects to this phone number.

  • SPL UNCLASSIFIED SECTION

    Distributed by Reckitt Benckiser LLC
    Parsippany, NJ 07054-0224

  • PRINCIPAL DISPLAY PANEL - 44 mL Bottle Carton

    NDC 63824-850-15

    SCALPICIN®

    MAXIMUM STRENGTH

    Hydrocortisone 1% Anti-Itch Liquid

    Anti-Itch Liquid

    MAXIMUM
    STRENGTH

    Relieves Scalp Itch

    1.5 FL OZ (44 mL)

    PRINCIPAL DISPLAY PANEL - 44 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SCALPICIN MAXIMUM STRENGTH 
    hydrocortisone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    glycerin (UNII: PDC6A3C0OX)  
    dipropylene glycol (UNII: E107L85C40)  
    menthol (UNII: L7T10EIP3A)  
    edetate disodium (UNII: 7FLD91C86K)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    tea tree oil (UNII: VIF565UC2G)  
    .alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-850-151 in 1 CARTON
    144 mL in 1 BOTTLE, DISPENSING
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/16/2012
    Labeler - Reckitt Benckiser LLC (094405024)
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